I have been following the issue of black-box warnings for antidepressant
medications since it came on the scene last year and would like to present
some observations and concerns knowing that APA is actively involved in the
safety and effectiveness of treatment for children and adolescents with
depression as was described in the March 4 issue.
Last year the data being presented by the Food and Drug Administration
involved a review of 4,400 subjects who were said to be "on" or"
taking" antidepressant medication. What struck me at the time was
that there was no reference to blood-level studies to prove that the subjects
actually ingested the medication and/or developed any kind of blood level,
that is, absorbed the medication and were not rapid metabolizers, for example.
I would hope that APA and the American Academy of Child and Adolescent
Psychiatry will pursue this particular aspect of the issue.